Guardian Supporter
"This product is a device that provides support by compressing or immobilizing certain parts of the body, such as the waist, knees, or neck. Including casting tape, but excluding those that…
“This product is a device that provides support by compressing or immobilizing certain parts of the body, such as the waist, knees, or neck. Including casting tape, but excluding those that do not provide support or reinforcement.”
10manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Henan (2), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Yangzhou Sensport Healthcare Supplies Co., Ltd. | Yangzhou | Jiangsu | Manufacturer | 27 |
| Zhengzhou Huaer Electro-Optics Technology Co., Ltd. | Zhengzhou | Henan | Contract manufacturer | 21 |
| Guangzhou Xinbo Electronic Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 18 |
| Shenzhen Jiding Electronic Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Pranash (Tianjin) Technology Development Co., Ltd. | Tianjin | Tianjin | Private-label distributor | 5 |
| Zhengzhou Magique Huaer Biotech Co., Ltd. | Zhengzhou | Henan | Manufacturer | 3 |
| Jiangxi Zhicheng Health Technology Co., Ltd. | Yingtan | Jiangxi | Manufacturer | 1 |
| Suichang Xiangdong Industry and Trading Co., Ltd. | Lishui | Zhejiang | Manufacturer | 1 |
Record
| Listed by | BM Korea Co., Ltd., South Korea |
|---|---|
| FDA product code | MNE |
| Device type | Orthosis, Moldable, Supportive, Skin Protective |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3475 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-06-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 155 to 560 mm; width 190 to 430 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GWT-M | Length 210 mm | In distribution |
| GWT-L | Length 215 mm | In distribution |
| GKC-L | Length 545 mm | In distribution |
| GAK-L | Length 175 mm | In distribution |
| GAK-M | Length 165 mm | In distribution |
| GKC-M | Length 530 mm | In distribution |
| GWT-XL | Length 220 mm | In distribution |
| GKC-XL | Length 560 mm | In distribution |
| GAK-S | Length 155 mm | In distribution |
| GKC-S | Length 515 mm | In distribution |
| GAK-XL | Length 185 mm | In distribution |
| GWT-S | Length 210 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DR -HOS | Guangzhou Xinbo Electronic Co., Ltd. | 7 |
| Orpyx Sensory Insoles | Orpyx Medical Technologies Inc. | 3 |
| Orpyx SI sensory insoles | Orpyx Medical Technologies Inc. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.